NCT05097534Completed
A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
To improve diabetes self-management outcomes, patients with type 2 diabetes (n=150 - aged 13-84) recruited from St. Vincent Clinic (SVC) and Teen Health Center Inc., Clinics will be randomized using block randomization to receive standard of care or the integrated model. Patients in the intervention arm will be assessed for social and physical needs before being enrolled in a year-long education program (iDSMES). Enrollees will receive dietary counseling, physical and occupational therapy, in addition to other mental, financial and social benefits counseling. The investigators will compare the intervention outcomes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 98 (actual)
- First submitted
- 22 Sept 2021
- Start date
- 7 Dec 2021
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Diseases
- Type 2 diabetes
- NCT number
- NCT05097534
What you commit to
- Study type: Interventional
- Participants enrolled: 98
- From 7 Dec 2021 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of type 1 diabetes
Other illness
- Inability to participate for 12-month duration (e.g., Disorders that might compromise survival, planning to relocate outside the geographical coverage of University of Texas Medical Branch (UTMB) clinics
- Other medical condition or medication administration deemed exclusionary by the study investigators
Age
- Ages \<13 or \>84
Other
- Pregnancy. If a subject becomes pregnant, they will advised to discontinue the study.
- Prisoners
Who the study is looking for
- Patients aged 13-84, and
- Patients diagnosed with type 2 diabetes, and
- Patients have a BMI equal to or \>25 (23, if Asians), and
- Hemoglobin A1c value equal to or \>7%
Age in the registry: 13 years to 84 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Vincent House Clinic Coordinator of this site? Confirm its status | Galveston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.